• Responsible for supporting sustenance projects and handling the labelling update for Kidney care Solutions and Containers Product portfolio. Able to handle the change controls related to labelling and other sustenance activities independently.
• Thorough understanding of the regulatory standards related to medical device labelling and ISO 13485 understanding.
• Good understanding of design control elements, hands on experience in preparing design documentation and exposure to quality tools.

 

Essential Duties and Responsibilities:
• As Tech Lead, considered to be the key focal point for execution of change controls related to labelling update and associated sustenance activities.
• In depth understanding of MDR requirements for medical devices
• Working experience of making art works and related documentation
• Define, organize, plan and execute activities related to change controls, own and execute the tasks related to changes.
• Work with multi-functional teams (engineering, marketing, manufacturing, regulatory, legal) to facilitate completion of labeling and design change execution.
• Timely completion of the execution efforts in compliance with the applicable regulations
• Single point of contact for the Drug products organization for the uploading and issuance of quality documents across all the modalities for SPO.
• Coordinate and ensure follow-up of technical activities in collaboration with key stakeholders, with respect of project commitment, quality procedures and business needs
• Propose options and develop action plan for problem-solving, product and process improvement in the area of scope of work
• Establish, maintain and update technical & Design documentation according to Good Documentation Practices
• Active Participation in multi-functional and global project team discussions.
• Ensure good internal and cross-functional communication and regular status update of activities
• Quick learner and ability to perform the role with minimal guidance

 

Qualifications:
• Bachelors in polymer science / engineering with a minimum of 5 years of relevant work experience
• Knowledge of product development stages, life cycle management and design control
• Working knowledge of international/regional/national regulations and standards related to Medical devices and labelling
• Understanding of MDR requirements
• Ability to work independently
• Ability to manage simultaneously several projects
• Ability to solve problems, develop solutions, and make recommendations in collaboration with senior technical leaders
• Ability to deliver results according to the plan
• Good communication skills

 

Education and Experience:
• Bachelors in polymer science / engineering
• Min 5+ years of relevant experience
• Experience in coordination of technical projects
• Excellent verbal and written communication skills